The American Association for Laboratory Accreditation

 The American Association for Laboratory Accreditation (A2LA) marks its 20th year of existence. Its major aim as a non-profit, public service organization is to promote laboratory quality and competence. In terms of the number of current accreditations, A2LA is the largest multidiscipline laboratory accreditation body in the United States and the fourth largest in the world. An overview of current activities and status is provided.     

Development of laboratory accreditation in the United States

 Laboratory accreditation in the United States is an old profession. Users and regulators have, it seems, been concerned about the quality of test data they obtain from laboratories for well over half a century. These users have developed many different systems to meet their needs. As a result, there is much duplication of effort and overlapping in accreditation requirements and many laboratories have to maintain current accreditation from a number of organizations. A number of attempts have been made over the years to reduce this duplication, but it still remains. In the meantime, rapid progress has been made internationally to recognize laboratory accreditation systems in different countries. This paper describes this situation and speculates on the future, considering the international thrust to simplify and consolidate conformity assessment procedures. Received: 26 May 1998 · Accepted: 6 June 1998     

Advances for proficiency testing for genetic laboratory science

Nucleic acid based clinical genetic testing has undergone explosive growth in recent years due in large part to the human genome project. Characterization of the human genome has led to a molecular understanding of the pathogenesis of many human diseases, and ultimately to clinical molecular tests becoming routinely used to diagnose a wide diversity of diseases. This rapid growth in clinical molecular genetic testing coupled with the complexity of the analytical procedures underscores the necessity for proficiency testing (i.e. external quality assessment) to allow laboratories offering such services the ability to evaluate their analytical procedures via inter-laboratory comparisons. The American College of Medical Genetics (ACMG) in partnership with the College of American Pathologists (CAP) have been offering proficiency testing for clinical molecular genetics laboratories since 1995, and presently have more than 230 laboratories from 11 countries enrolled in this program. This paper describes the evolution of this program and several challenges encountered in the delivery of a proficiency testing program for laboratories offering clinical molecular genetic services. Received: 13 April 2002 Accepted: 18 July 2002     

Pathology laboratory accreditation: the Australian experience

 The National Associating of Testing Authorities, Australia (NATA) is a laboratory accreditation company that has been involved in the accreditation of pathology laboratories since 1982. This role is carried out in conjunction with the Royal College of Pathologists of Australasia (RCPA). The accreditation process is known as the NATA/RCPA scheme. The NATA/RCPA accreditation scheme originated from the desire to raise professionalstandards in pathology. The scheme aimed to achieve this through a peer review process in which education and voluntary participation were stressed. In 1986, the Australian Federal Government adopted the scheme as its measure of the competence of testing by pathology laboratories seeking payment from the Commonwealth Department of Human Services and Health reimbursement scheme, Medicare. This meant that NATA/RCPA accreditation became mandatory for such laboratories. The benefits of peer review as a means for establishing professional competence and the challenges a mandatory accreditation program poses to such a scheme will be discussed. Received: 6 May 1996 Accepted: 29 May 1996     

Quality assurance programs for countries in need: a global view from the College of American Pathologists

Providing laboratory external quality assessment (EQA) programs for countries in need requires special considerations not ordinarily part of EQA for laboratories in industrialized countries. Cultural, professional, service and economic factors must be understood and accommodated in order to carry out successful programs. Coordination of worldwide efforts for countries in need requires more resources and planning than have thus far been devoted to the enterprise.     

Sense and nonsense of laboratory accreditation

 An open mind is essential for the implementation and improvement of total quality management. Leadership, as such, is of no value without a vision concerning corporate culture and human resources. Therefore, constant communication between partners within a corporate body is the cornerstone for empowerment. The evaluation of ideas and complaints is considered to be essential for the identification of strengths and weaknesses of a system, whereas, competition and benchmarking may reveal surprising opportunities for improvement. We discuss the idea that customer-oriented efficiency in a hospital environment may be classified as a critical success factor.     

Getting the most from your laboratory information system in the hematology laboratory

As laboratories continue to downsize, commercialize and become more businesslike in today’s managed care environment, their present and future success will greatly depend on the efficiency and flexibility of their laboratory information system (LIS). Today, LIS is a primary tool for managing business and communication. Laboratories that hope to remain competitive in today’s dynamic health care must continue to implement new and innovative approaches with their LISs. Received: 26 July 2002 Accepted: 6 August 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium     

Is accreditation useful for quality improvement?

 The Laboratory of the Government Chemist (UK) and the Institute for Reference Measurements and Materials (Belgium) evaluated the correlation between accreditation and performance in proficiency tests. It was concluded that accreditation does not have the expected positive effect on the quality of laboratory results. In this journal discussions conducted on this subject during the CITAC workshop at Pittcon in 1998, were published. No satisfactory explanation for this phenomenon was put forward. In this article, it is proposed that the main effect of accreditation is a decrease of intralaboratory spread. The effect on the trueness of laboratory results is not significant due to the lack of certified reference materials and the low frequency of participation in proficiency tests. Proficiency tests cannot be used to find a correlation between accreditation status and quality without changing the set-up of the proficiency test.     

Basic steps towards a self-sustainable quality system and laboratory accreditation

 Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality management on their own, some recommendations are given for a path towards a self-sustaining quality system. Several practical aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories. Received: 5 June 1997 · Accepted: 7 December 1997     

The correlation of laboratory performance in proficiency testing with other QA characteristics

Although it seems self-evident that proficiency testing (PT) and accreditation can be expected to improve quality, their relative benefits remain uncertain as does their efficacy. The study reported here examines the following issues: (a) Why do laboratories take part in PT schemes? (b) How does participation in PT fit in with a laboratory's overall quality assurance (QA) system? (c) Is there a link between a laboratory's performance in specific PT and it's QA system? (d) How does PT performance change with time and how do laboratories respond to poor performance? The overall conclusion is that there is no evidence from the present study that laboratories with third-party assessment (accreditation and certification) perform any better in PT than laboratories without. The validity of this conclusion and its significance for the future design and operation of such schemes requires further investigation. In particular, study is required of the degree to which good performance in open PT correlates with blind PT performance, where laboratories are not aware that the samples being analysed are part of a quality assessment exercise.     

The attitude of laboratory personnel towards accreditation

 A multiple-choice questionnaire was submitted to medical technologists in two medical laboratories, 10 months after the laboratories had obtained an EN 45001 (Beltest) accreditation. The majority of the technologists (85–90%) considered that their workload had been increased by the accreditation process but they did not think that the process had improved the quality of their results. The major advantages were: traceability, the fact that the technologists felt more confident about the procedures followed, they also received more responsibility and had a better knowledge of the tests performed. The major disadvantages were the increased paperwork, discrepancies between written procedures and the same procedures in practice, the fact that more attention was paid to the formalities rather than to the quality of the results and that the accreditation process decreased the technologists' adaptability. A small majority of the technologists prefered working in an accredited laboratory rather than in a non-accredited one. Received: 5 October 1998 · Accepted: 20 October 1998     

Statistical treatment of proficiency testing data

 There are three stages to evaluating a laboratory's results in an interlaboratory proficiency test: establishing the correct result for the test item, determining an evaluation statistic for the particular result, and establishing an acceptable range. There are a wide variety of procedures for accomplishing these three stages and a correspondingly wide variety of statistical techniques in use. Currently in North America the largest number of laboratory proficiency test programs are in the clinical laboratory field, followed by programs for environmental laboratories that test drinking water and waste water. Proficiency testing in both of these fields is under the jurisdiction of the federal government and other regulatory and accreditation agencies. Many of the statistical procedures are specified in the regulations, to assure comparability of different programs and a fair evaluation of performance. In this article statistical procedures recommended in International Organization for Standardization Guide 43, Part 1, are discussed and compared with current practices in North America. Received: 22 April 1998 · Accepted: 12 May 1998     

The experience of accreditation of an analytical laboratory at the Argentine Atomic Energy Commission

The implementation of a quality system based on the ISO/IEC 17025:1999 standard is a growing necessity for analytical laboratories to demonstrate their technical competence. In 2001, the Nuclear Analytical Techniques Group of the Argentine Atomic Energy Commission obtained the recognition of the International Atomic Energy Agency in the application of neutron activation analysis and the accreditation by the national accreditation body. The importance of the participation of the group in the Agency's Regional Programme for Latin America, ARCAL XXVI on Quality Assurance in Analytical laboratories is discussed, as well as the activities performed to attain these objectives. Some improvements worth mentioning resulted from the implementation of the quality system and, following the premise of continuous improvement, changes were introduced aiming at the laboratory re-accreditation.     

Environmental analysis in the Czech Republic: organisation of proficiency testing and its use in laboratory assessment

The history, origin, and development of a system for monitoring and assessing water and other environmental laboratories in the Czech Republic is described. The system started in 1991 and has matured to its present complexity with similarities to the accreditation systems found in other countries. Differences from internationally recognized procedures are being corrected step by step. During the first year of its existence ASLAB, as part of its brief, organised proficiency testing (PT) programs for fifty laboratories. Today the total number of regularly participating laboratories exceeds 700 from the Czech Republic, the Slovak Republic, and Germany. This paper describes the ASLAB PT system, discusses some experiences with its use, and describes the use of PT results in assessment of the competence of laboratories. Received: 12 October 2000 Accepted: 7 January 2001     

How autoverification through the expert system VALAB can make your laboratory more efficient

For over 10 years now various expert systems have been on the market, but very few have reached the level of performance of Validation Assistée pour les Laboratoires d’Analyses Biologiques (VALAB). Over 25,000 rules are combined through an inference engine to reproduce human reasoning in the complex ”biological validation” process. After a review of the product concept and its development program, we will see how this ”intelligent” tool can bring quality to clinical laboratories, from a production as well as legislation point of view. With more than 140 laboratories using VALAB in Europe in daily routines, our designer and vendor experience in installation, maintenance, upgrading, reliability, efficiency, and liability is excellent. Received: 9 October 2001 Accepted: 22 July 2002 Presented at the European Conference on Quality in the Spotlight in Medical Laboratories, 7–9 October 2001, Antwerp, Belgium Correspondence to E. Rogari     

Benefits arising from proficiency testing schemes: The comparison of analytical methods

 The primary objective of proficiency testing (PT) is in the provision of information and support to participating laboratories, to enable them to monitor and improve the quality of their measurements. However, other benefits can be obtained from PT. These include the comparison of data for a given measurement by different methods, the validation of new methods, and the provision of information for laboratories' customers and accreditation bodies. This paper considers the subject of method comparison, and highlights some of the approaches which can be followed, as well as the practical use to which this can be put, to benefit the analytical community more widely. This is illustrated by a case study concerning the measurement of haze in beer. In this study the United Kingdom Institute of Brewing (IoB) conducted a survey of participants in the Brewing Analytes Proficiency Scheme (BAPS). From the survey data taken together with data from the BAPS scheme, the IoB is now in a position to give guidance on the use of particular instruments and procedures, as well as consider changes to the scope of the BAPS scheme to provide greater benefits for participants concerned with measuring haze. Received: 3 March 1998 · Accepted: 9 June 1998     

Quality in clinical laboratory measurements

 Clinical chemistry deals with measurements and observations using samples from patients in order to supply clinicians with information to support their decisions in diagnosis and treatment. The discipline utilizes advanced chemical and biochemical methods and also sophisticated instrumentation which allows a high throughput. Clinical chemistry has a long tradition of quality assessment and improvement. The major tools have been proficiency testing or external quality assessment and internal quality control. Nowadays, total quality management has become widely recognized, and accreditation according to international, regional or national schemes has contributed to the design of quality systems and improvement of the reliability of results from clinical laboratories.     

The Operational System of National Accreditation of Laboratories in China

This document gives a brief introduction to CNACL (China National Accreditation Committee for Laboratories). Laboratory accreditation in China is integrally administrated by the China State Bureau of Quality and Technical Supervision, a government administrative department of China State Council, which authorizes CNACL to implement Chinese laboratory accreditation activities. CNACL was established on September 20, 1994. It is a full member of both ILAC (International Laboratory Accreditation Cooperation), and APLAC (Asia Pacific laboratory Accreditation Cooperation), and signed the APLAC MRA (Mutual Recognition Arrangement) in New Delhi, India on December 3, 1999. CNACL carries out laboratory accreditation activities in full compliance with international general criteria. Its operation complies with ISO/IEC Guide 58 (1993), ISO/IEC 17025 (1999), ISO/IEC Guide 43 (1997) and other international standards.     

The application of data from proficiency testing to laboratory accreditation according to ISO 17025

Current methods of testing laboratories for their proficiency in reporting correct measurement results are liable to substantial errors of the second kind. This means that laboratories with deflated uncertainties are accepted as proficient, even though their reported measurement results pave the way for erroneous conclusions. Only by using E _n numbers based on an accepted reference value with the lowest possible uncertainty can the risk of recognising incorrect measurement results be kept at an acceptable level. Based on an actual set of proficiency test (PT)-data for the concentration of Pb in water, this paper compares PT results obtained by methods using E _n numbers with methods based on z-scores. Kaj Heydorn is a technical assessor at The Danish Accreditation and Metrology Fund (DANAK).